Genzyme transfers fill/finish to meet 1st decree deadline

By Nick Taylor

- Last updated on GMT

Related tags: Consent decree, Pharmaceutical drug, Food and drug administration, Us

Genzyme met its first consent decree deadline by transferring all fill/finish of US products from its Allston plant to its site in Ireland and Hospira.

Transferring fill/finish of products for sale in the US away from the plant in Allston, Massachusetts by November 28 was the first in a number of tasks in a consent decree with the US Food and Drug Administration (FDA). Genzyme shares were up $1.06 following release of the news.

Fill/finish of products for sale in the US will now be performed on a contract basis by Hospira and at the Genzyme plant in Waterford, Ireland. Genzyme is now working with regulators to transfer fill/finish of products for sale outside the US must away from Allston by August 31 2011.

Completion of the first phase of fill/finish transfer lifts restrictions on the marketing and distribution of Thyrogen (thyrotropin alfa for injection) within the US. Also, it represents a positive step in its recovery from manufacturing difficulties and attempt to secure more than $69 a share if acquired.

Cerezyme (imiglucerase for injection), Myozyme (alglucosidase alfa) and Fabrazyme (agalsidase beta) are the other products transferred from Allston by Genzyme.

KV gains time to pay fine

KV Pharmaceutical, another company with an FDA consent decree, this week had its fine payment changed by the US District Court of Eastern Missouri. Deadline for final payment has been extended by 18 months and the amount payable in fiscal 2011 cut by $9m (€6.8m).

The payment schedule is now: $1m in December; $1m in June 2011; $1m in December 2011; $2m in June 2012; $4m in December 2012; $5m in June 2013; and $7.1m in December 2013.

Related topics: Ingredients, QA/QC, Processing equipment

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